A randomized clinical trial to study the effect of Reflexology therapy along with conventional therapy in children with spastic cerebral palsy

Phase 2

Recruiting

Conditions: Spastic cerebral palsy

Registration Number: CTRI/2010/091/001414

Lead Sponsor: All India Institute of Medical Sciences

Brief Summary: The proposed research project was a randomized clinical trial in determining the efficacy of reflexology therapy in addition to the ongoing conventional therapy in children with spastic cerebral palsy. Cerebral Palsy describes a group of disorders of the development of movement and posture, causing activity limitations that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, cognition, communication, perception and/or by a seizure disorder. Spastic cerebral palsy is the most common form of Cerebral Palsy. The incidence is 2 to 2.5 per 1000 live births. It is estimated that there are 25, 00,000 persons with cerebral palsy in India. Cerebral palsy cannot be cured but by multi disciplinary management all the problems can be addressed. The goals of management should be to use appropriate combinations of interventions (e.g., developmental, physical, medical, surgical, chemical and technical modalities) to promote function, to prevent secondary impairments and to increase the childs developmental capabilities. In recent time there has been considerable interest in "complementary and alternative medicine (CAM) among the population in Asia, UK, USA and other parts of globe which has been combined with the conventional therapies treatment so that the individual patient can get maximum benefits. It has been observed that even the adequate pharmacological therapies and surgical procedure do not offer a complete management of spastic cerebral palsy. In view of this, the proposed study presents another mode of intervention in addition to the existing ones to observe the effect of reflexology therapy in the management of spastic cerebral palsy. This will be helpful in establishing reflexology as a low cost medical system with least side effect. This study is a Randomized, parallel group, active controlled trial comparing the efficacy of reflexology + conventional therapy in children with spastic cerebral palsy to the conventional therapy alone for a period of six months in 176 patients with spastic cerebral palsy that will be conducted at Dept of Biophysics, All India Institute of Medical Sciences, New Delhi. The primary outcome measure will be the change in Gross Motor Function Measure (GMFM) score at the end of six months from the date of patients enrollment for this study. The secondary outcome measure will be the change in spasticity in children with spastic cerebral palsy as measured by Modified Ashworth Scale (MAS) and to measure the Range of Motion (ROM) by Goniometry at the end of six months.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 176

Inclusion Criteria

Children with a diagnosis of spastic cerebral palsy and mixed cerebral palsy.
Patients with spastic cerebral palsy with conventional medical treatments (on oral anti spasticity drugs + Physio and occupational therapy) 4.Patients who are residents of Delhi or have arrangement for stay over Delhi / NCR for a minimum duration of 10 weeks for training the caregivers and monitoring the health conditions of the subjects at each step of therapy session.

Exclusion Criteria

1.Fixed contractures 2.Children with severe intractable epilepsy as co morbidities3.Children had received botox (last 1 yr) or has undergone phenol block injection and intrathecal baclofen medication4.Care giver not willing to sign the informed consent form.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gross Motor Function Measure (GMFM)Score	6 months

Secondary Outcome Measures

Name	Time	Method
1. Modified Ashworth scale (MAS)- change in spasticity score at elbow flexors and wrist flexors in upper limb and knee flexors, plantar flexors and hip adductors in the lower limb from baseline to follow up data.	2. Range of Motion (ROM) measured by goniometry in lower limb at popliteal angle, ankle dorsiflexion angle and hip adduction angle from baseline to follow up data.

Trial Locations

Locations (1): Department of Biophysics, All India Institute of Medical Sciences, NEW DELHI
🇮🇳
Delhi, DELHI, India
Department of Biophysics, All India Institute of Medical Sciences, NEW DELHI
🇮🇳Delhi, DELHI, India
Dr V Bharathi Maran
Principal investigator
011-26593215
vbmaran@gmail.com